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Completed

NCT Number: NCT01710332

The Safety & Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy

A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mid Atlantic Retina- Huntingdon Valley, Huntingdon Valley, Pennsylvania, United States

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About this study

Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pre-treatment acuity of 20/40- 20/320
  • Macular fluid on optical coherence tomography for greater than 3 months
  • Leakage on fluorescein angiography
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Exclusion criteria

  • Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months prior to study enrollment
  • Presence of choroidal neovascularization on enrollment imaging
  • Prior vitrectomy in the study eye
  • Presence of any substantial ocular disease (other than CSCR) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication)
  • Active ocular infection or inflammation in the study eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Prior treatment with systemic anti-VEGF agents
  • Cerebrovascular accident or myocardial infarction within the preceding 6 months.
  • History of allergy to fluorescein, povidone iodine (Betadine) or aflibercept
  • Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
  • Pregnant or breast-feeding women Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
  • Contraception is not required for men with documented vasectomy.
  • Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Treatment and study plan

Intravitreal aflibercept injection

Drug

GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).

GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).

Other names: Eylea

Primary outcomes

  1. Safety of Intravitreal Aflibercept Injection

    Time frame: 6 months

    Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.

Secondary outcomes

  1. Change in Vision Based on Letter Score

    Time frame: 6 months

    • Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study

Acronym: CONTAIN

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2012
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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